BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI STERNAL FIXTN KIT/X-PL W/12MM SLF-DRLG SCR-STERILE

    MDR report key: 4251501 · Received November 14, 2014

    Report

    Report Number
    2520274-2014-14753
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 1, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    PK093772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE USE OF MATRIXRIB SCREWS IN TITANIUM STERNAL FIXATION SYSTEM (TSFS) PLATES IS OFF-LABEL USE OF THESE SYSTEMS. THE MIXTURE OF DIFFERENT PRODUCTS IS NOT APPROVED BY THE MANUFACTURER AND CAN NOT BE COMMENTED ON. THE FIRST ON-LABEL USE (AS DESCRIBED IN THE COMPLAINT) OF THE TSFS PLATE (460.036) WITH TSFS SELF DRILLING SCREWS OF DIFFERENT LENGTHS, CAN NOT BE EVALUATED SINCE MATRIXCRIB SCREWS HAD BEEN INSERTED INTO THE SAME LOCATION AND MAY HAVE ALTERED THE SITUATION.THEREFORE, PRODUCT DEVELOPMENT CAN NOT INVESTIGATE THIS COMPLAINT AND CLOSES THIS INVESTIGATION AS IN-VALID. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION/ASSEMBLING OF THIS KIT. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE VISUAL INSPECTION HAS SHOWN THAT THE PLATE HAS NO VISIBLE DAMAGES. WE FOUND THAT THE FIRST THREAD FLANKS AT THE LOCKING THREAD OF ENCLOSED STERNAL UNILOCK SCREWS IS DAMAGED. BUT EVEN WITH THIS DAMAGE THE SCREWS ARE STILL FUNCTIONAL AND CAN BE LOCKED IN THE PLATE AS DESIGNED. ALSO WE FOUND THAT THE CRUCIFORM RECESS AT BOTH SCREW IS BADLY DAMAGED, WHICH INDICATES THAT HIGH FORCES WERE APPLIED ONTO THESE SCREWS. THE PASSIVATED LAYER IS WORN OUT AT ALL DAMAGES, WHICH INDICATES THAT THEY WERE CAUSED POST-MANUFACTURING, BUT AFTERWARDS IT IS IMPOSSIBLE TO DEFINE IF THIS OCCURRED DURING INSERTION OR EXTRACTION. BASED ON THE COMPLAINT DESCRIPTION WAS THERE AN ISSUE DURING SURGERY WITH FIXING THE PLATE WITH THE INTENDED STERNAL UNILOCK SCREWS OF THIS STERNAL PRIMARY KIT, WHICH MADE THE USE OF ALTERNATIVE SCREWS NECESSARY. THERE WAS NO INFORMATION ABOUT THE ISSUE WITH THE UNILOCK SCREWS PROVIDED AND THE SCREWS IN QUESTION WERE NOT SENT BACK FOR INVESTIGATION. THIS MAKES A CONCLUSIVE STATEMENT REGARDING THIS ISSUE IMPOSSIBLE. THE REVIEW OF THE MANUFACTURING DOCUMENTS OF THIS STERNAL PRIMARY KIT HAS SHOWN THAT THE PLATE AND THE SCREWS WERE MANUFACTURED ACCORDING TO THE SPECIFICATION. THE KIT WAS MANUFACTURED WITH A LOT SIZE OF 19 PIECES IN MARCH 2013 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER. THIS COMPLAINT IS UNCONFIRMED FOR THE STERNAL PRIMARY KIT AS THERE WAS NO INFORMATION ABOUT THE ¿ISSUE¿ WITH THE STERNAL UNILOCK SCREWS PROVIDED AND AS A DISLODGING OF THE STERNAL UNILOCK SCREWS FROM THE PLATE IS NOT VISIBLE ON THE RECEIVED PICTURES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. THIS KIT INVOLVES 2 PLATES AND 16 SCREWS. TWO SCREWS DISLODGED FROM PLATE. ADDITIONAL PRODUCT CODE: HWC. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON HAD AN ISSUE DURING SURGERY FIXING THE PLATE WITH THE SELF-DRILLING SCREWS IN THE KIT. THE ONLY OTHER SCREWS AVAILABLE WERE MATRIX RIB SCREWS. THE PLATE WAS FIXED AND PATIENT WAS CLOSED. THE PATIENT RETURNED TO SURGERY DUE TO SCREWS DISLODGING FROM PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737947 TI STERNAL FIXTN KIT/X-PL W/12MM SLF-DRLG SCR-STERILE PLATE, FIXATION, BONE HRS SYNTHES MONUMENT 460.146S 7292732

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention